Schiller AT-2 User manual

AT-2

Article Number 2. 510 512

*2. 510 512*

AT-2 User Guide

AT-2

12 Channel ECG Unit

AT-2

User Guide

AT-2 User Guide

CARDIOVIT AT-2

User Guide

Art. No. 2.510 512 Rev b

March 2004

SCHILLER AMERICA Inc.,

11300 NW 41st Street,

Miami, FL 33178

Telephone: +1 786 845 06 20

sales@schilleramerica.com

www.schilleramerica.com

AT-2 User Guide

Intended Use

The SCHILLER Cardiovit AT-2 is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG Recordings. Recordings made with the AT-2 can be used as a diagnostic aid for heart function and heart conditions. The unit is designed for indoor use and can be used for all patients of both sexes, all races, and all ages.

Physician`s Responsibility

The Cardiovit AT-2 ECG Unit is provided for the exclusive use of qualified physicians or personnel under their direct supervision. The numerical and graphical results and any interpretation derived from a recording must be examined with respect to the patient`s overall clinical condition. Patient preparation and the general recorded data quality, which could effect the report data accuracy, must also be taken into account.

It is the responsibility of the physician to make the diagnosis or to obtain expert opinion on the results, and to institute correct treatment if indicated.

FEDERAL LAW IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

AT-2 User Guide

Contents

Intended Use ......................................................................................................................................... 3

Physician`s Responsibility ..................................................................................................................... 3

Terms of Warranty ................................................................................................................................. 7

Disposal Instructions and Battery Care ................................................................................................. 8

EMC Complicity ..................................................................................................................................... 8

Power Supply ........................................................................................................................................ 9

Changing a Mains Fuse ........................................................................................................................ 9

Safety Notices ..................................................................................................................................... 10

Safety Notices ......................................................................................................................................11

Symbols and Conventions Used in this User Guide ............................................................................ 12

Introduction ................................................................................................................................................. 13

Modes of Operation ..................................................................................................................................... 15

Automatic Mode .................................................................................................................................. 15

Manual Mode ...................................................................................................................................... 15

Location & Power ........................................................................................................................................ 16

Location .............................................................................................................................................. 16

Power Supply ...................................................................................................................................... 16

Switching On and Off .................................................................................................................................. 17

Potential Equalisation .......................................................................................................................... 17

AT-2 User Guide

Keyboard ...................................................................................................................................................... 18

Patient Cable Connections ......................................................................................................................... 20

Electrodes and Neutral Electrodes Identification and Color Code ...................................................... 22

Electrode Placement - Standard Configuration ................................................................................... 23

Operating Overview .................................................................................................................................... 24

Automatic Mode .................................................................................................................................. 24

Manual Mode ...................................................................................................................................... 26

Changing the Lead Group ................................................................................................................... 27

Chart Speed ........................................................................................................................................ 28

Sensitivity ............................................................................................................................................ 28

Myogram Filter .................................................................................................................................... 28

Recentering ......................................................................................................................................... 28

Settings ........................................................................................................................................................ 29

Default Settings ................................................................................................................................... 31

Language ............................................................................................................................................ 33

Filters .................................................................................................................................................. 34

Baseline .............................................................................................................................................. 35

Mains Filter .......................................................................................................................................... 36

Myogram Filter .................................................................................................................................... 36

Defining Lead Sequence & Printout .................................................................................................... 38

Acoustic QRS Indication ..................................................................................................................... 40

Time / Date .......................................................................................................................................... 40

Automatic Mode (ECG) Settings ................................................................................................................ 41

Average Cycles ................................................................................................................................... 43

AT-2 User Guide

Measurements and Markings (C version only) .................................................................................... 44

Interpretation (C version only) ............................................................................................................. 45

Interpretation Settings (C version only) ............................................................................................... 46

Selecting Rhythm Leads ..................................................................................................................... 47

Care & Maintenance .................................................................................................................................... 49

Self-test ............................................................................................................................................... 49

12 Monthly Check ............................................................................................................................... 49

Cleaning the Casing ............................................................................................................................ 50

Cleaning the Patient Cable ................................................................................................................. 51

Cleaning the Thermal Print Head ........................................................................................................ 51

Replacing the Recording Paper ................................................................................................................. 52

Thermal Paper Handling ..................................................................................................................... 53

Fault Diagnosis............................................................................................................................................ 54

Ordering Information .................................................................................................................................. 56

Technical Data ............................................................................................................................................. 57

Available Configurations ..................................................................................................................... 60

AT-2 User Guide

Terms of Warranty

The SCHILLER Cardiovit AT-2 is warranted against defects in material and manufacture for the duration of one year (as from date of purchase). Excluded from this guarantee is damage caused by an accident or as a result of improper handling. The warranty entitles free replacement of the defective part. Any liability for subsequent damage is excluded. The warranty is void if unauthorized or unqualified persons attempt to make repairs.

In case of a defect, send the apparatus to your dealer or directly to the manufacturer. The manufacturer can only be held responsible for the safety, reliability, and performance of the apparatus if:

° assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by him, and

° the Cardiovit AT-2 and approved attached equipment is used in accordance with the manufacturers instructions.

THERE ARE NO EXPRESS OR IMPLIED WARRANTIES WHICH EXTEND BEYOND THE WARRANTIES HEREINABOVE SET FORTH. SCHILLER MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCT OR PARTS THEREOF.

This equipment has been tested and found to comply with the limits for a class A digital device, pursuant to both Part 15 of the FCC (Federal Communications Commission) Rules and the radio interference regulations of the Canadian Department of Communications. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with this instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

AT-2 User Guide

Disposal Instructions and Battery Care

° DO NOT DISPOSE OF THE BATTERY BY FIRE OR INCINERATOR - DANGER OF EXPLOSION

° DO NOT OPEN THE BATTERY CASING - DANGER OF ACID BURN

Only dispose of the battery in official recycling centres or municipally approved areas. Alternatively, used batteries can be returned to SCHILLER AG for disposal.

Units no longer required can be returned to SCHILLER AG for disposal. Alternatively dispose of the unit in municipally approved recycling centres.

EMC Complicity

AT-2 User Guide

Power Supply

The mains connection is on the rear of the unit. The power supply voltage is set by the factory for 100-115V(nom. 110V) working. The setting is indicated by the indented metal strip on the fuse panel. Contact your dealer if the voltage needs to be changed.

The mains indicator lamp on the keyboard is always lit when the unit is connected to the mains supply. The unit can either be operated from the mains supply or from the built-in rechargeable battery.

Changing a Mains Fuse

Always replace a damaged fuse with the correct rating i.e. 2x315mAT for 110V working.

To change a fuse press the two retaining lugs on side of the fuse panel (situated below the mains connector on the back panel). Remove the fuse panel and replace the fuse(s). Click back the fuse panel.

AT-2 User Guide

Safety Notices

 Before using the unit, ensure that an introduction regarding the unit functions and the safety precau-

tions has been provided by a product representative.

 This product is not designed for sterile use.

 This product is not designed for internal use.

 This product is not designed for outdoor use.

 Surface temperature of applied parts must not exceed 41

 Use only accessories and other parts recommended or supplied by SCHILLER AG. Use of other than

recommended or supplied parts may result in injury, inaccurate information and/or damage to the unit.

 Do not use high temperature sterilization processes (such as autoclaving). Do not use e-beam or

gamma radiation sterilization.

 Do not use solvent or abrasive cleaners on either the unit or cable assemblies.

 Do not, under any circumstances, immerse the unit or cable assemblies in liquid.

 To prevent electric shock do not disassemble the unit. No serviceable parts inside. Refer

servicing to qualified personnel only.

 To prevent electric shock do not disassemble the unit. No serviceable parts inside. Refer

servicing to qualified personnel only.

 Do not use this unit in areas where there is any danger of explosion or the presence of

flammable gases such as anaesthetic agents.

Safety Notices

AT-2 User Guide

 Switch the unit off before cleaning and disconnect from the mains.

 Do not, under any circumstances, immerse the unit or cable assemblies in liquid.

 The device must only be operated using battery power if the earth connection is suspect or if

the mains lead is damaged or suspected of being damaged.

 The AT-2 complies with emc regulations for medical products which affords protection against

emissions and electrical interference. However special care must be exercised when the unit is used with high frequency equipment.

 It must be ensured that neither the patient nor the electrodes (including the neutral electrode)

come into contact with other persons or conducting objects (even if these are earthed).

 There is no danger when using the ECG unit for a pacemaker patient or with simultaneous

use of other electrical stimulation equipment. However, the stimulation units should only be used at a sufficient distance from the electrodes. In case of doubt, the patient should be disconnected from the recorder.

 This unit is cf classified according to iec 601-1. This means that the patient connection is fully

isolated and defibrillation protected. SCHILLER can only guarantee protection against defibrillation voltage however, when the original SCHILLER patient cable is used.

 If several units are coupled there is a danger of summation of leakage current

 Do not touch the casing during defibrillation.

 if the patient cable should become defective after defibrillation, lead off will be displayed and

an acoustic alarm given.

AT-2 User Guide

Symbols and Conventions Used in this User Guide

WARNING:

Specific warning applicable to associated instruction. Text set off in this manner indicates that failure to follow directions could result in bodily harm or loss of life.

NOTE:

Text set off in this manner presents clarifying information, specific instructions, commentary, sidelights, or interesting points of information.

CF Symbol. Unit is classified safe for internal and external use. The paddles at the side indicate

that the unit is defibrillation protected when the original SCHILLER patient cable is used.

Potential Equalisation Point.

The unit /component can be recycled.

Type and approving body.

Introduction

The SCHILLER Cardiovit AT-2 is an ECG recorder with all (12) ECG signals simultaneously processed to provide instant ECG recordings. Two automatic recording modes can be individually preset to enable one button ECG recording of preferred print formats.

Individual lamps are provided to give power, paper error, filter, lead group and lead off indications. In addition, any detected disturbance (i.e. loose electrode or end of paper), gives an audible alarm and the corresponding indicator lamp flashes.

The AT-2 includes the following features:

° Low weight and compact dimensions. ° Large A4 size printout from integrated

quality thermal printer.

° Built-in rechargeable battery for mains-

independent use - 4hrs normal use or 300 printouts on one battery charge.

° Simple one key operation for main

functions. ° Automatic or manual recording modes. ° Selectable printing formats ° Interpretation program option (including measurements) for children and adults.

AT-2 User Guide

Modes of Operation

Automatic Mode

Automatic Mode provides a printout giving 10 seconds of ECG recording of all 12 leads with a choice of 2 different formats.

The following can be programmed freely for each of the 2 formats before recording:

° Lead Format

° Chart Speed

° With the optional interpretation program installed it is also possible to select the measurement table, average

cycles with optional markings and interpretation statements for the printout.

For further information see sections `Operating Overview` and `Settings for Automatic Mode`.

Manual Mode

Manual Mode provides a real time printout of 6 leads that are selected and indicated on the screen.

The following can be freely selected before or during recording:

° Lead Group

° Chart Speed

° Sensitivity

° Myogram Filter

For further information see section `Operating Overview` - Manual Mode.

AT-2 User Guide

Location & Power

Location

Do not keep or operate the apparatus in a wet, moist, or dusty environment. Also, avoid exposure to direct sunlight or heat from other sources. Do not allow the unit to come into contact with acidic vapours or liquids, as such contact may cause irreparable damage. The unit should not be placed near X-ray or diathermy units, large transformers or motors. The unit must be placed on a flat surface and must not be operated in areas where there is any danger of explosion.

Power Supply

The unit can either be operated from the built-in rechargeable battery, or from the mains. The mains connection is on the rear of the unit. The mains indicator lamp is always lit when the unit is connected to the mains supply.

A battery indicator lamp confirms battery operation. When battery capacity is limited, the battery symbol flashes on and

off.

To recharge the battery, connect the apparatus to the mains supply by means of the supplied power cable. A totally discharged battery needs less than 15 hours to be fully recharged (60% in less than 3 hours, 90% in less than 7 hours). A fully charged battery gives approximately 4 hours of normal use. The unit can remain connected to the mains supply without any danger of damage to either the battery or the unit.

AT-2 User Guide

Switching On and Off

The Cardiovit AT-2 is switched on with the ON key

and off by means of the OFF key

The unit is automatically switched off after 5 minutes (30 seconds if battery capacity is limited) if no key is pressed and the patient cable is not connected.

Potential Equalisation

If the AT-2 is used in conjunction with other patient connected equipment, we recommend that the potential equalisation stud on the rear of the unit is connected to the hospital/ building common ground with the yellow/green ground cable (Part-no. 2.310005). When working from an emergency vehicle, the vehicle common ground can be used.

AT-2 User Guide

Keyboard

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